Medical device package vacuum sealer and burst tester

ABSTRACT

One example embodiment includes a system for sealing and burst testing a medical device package. The system includes a nozzle, where the nozzle is configured to be inserted into a medical device package. The system also includes an air pump, where the air pump is configured to remove air from the medical device package through the nozzle and insert air into the medical device package through the nozzle for burst testing. The system further includes a sealer, where the sealer is configured to seal the medical device package.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not applicable.

BACKGROUND OF THE INVENTION

Packages sealed by medical sealers must meet government standards;therefore, the seal integrity of packages must be routinely testedduring production to assure there will be no loss of device sterility.There are different tests for evaluating seal strength and integrity,the most common being peel testing, burst testing and visual testing.Peel testing is a common way to determine seal strength utilizingdestructive methodology. Burst testing is another common testmethodology for whole pouch testing to understand package limits bysacrificing pouch through air inflation to the point of burst.

These test modalities are used when developing the preliminary Design ofExperiments for the validation processes, as well as for routine testingfor the process of quality assurance. The visual process is used mostoften as an in-process system of seal inspection as it isnon-destructive. Peel testing measures the strength of seal in pounds,or newtons, while visual testing analyzes seal integrity for anomaliessuch as pleating, cracking, bubbling, etc. Burst testing providesfeedback as to the total package value, as seals and material are pushedto discover the weakest point of the pouch.

However, basic medical pouch sealers used in the art today do notinclude a mechanism for thorough evaluation of whole package totalstrength. Currently, when a medical packager seals a pouch using amedical sealer, he or she must occasionally pull a pouch out ofproduction to test the seal. Testing the seal usually involve taking thepouch to a lab where the material is cut into a one-inch strip andpulling the material apart using, for example, an industrial ASTM F-88seal strength test to determine the integrity of the seal. This can leadto a lag time in discovering problems in medical device packageintegrity. In particular, problems may not become apparent for some timewhich means more medical devices that have to be repackaged and a lossof production time.

Accordingly, there is a need in the art for a system that is capable ofcompleting medical device package testing for the whole medical devicepackage. Additionally, there is a need in the art for the system to testthe medical device package at the site of sealing. Further, there is aneed in the art for the system to discover problems quickly.

BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential characteristics of the claimed subject matter, nor is itintended to be used as an aid in determining the scope of the claimedsubject matter.

One example embodiment includes a system for sealing and burst testing amedical device package. The system includes a nozzle, where the nozzleis configured to be inserted into a medical device package. The systemalso includes an air pump, where the air pump is configured to removeair from the medical device package through the nozzle and insert airinto the medical device package through the nozzle for burst testing.The system further includes a sealer, where the sealer is configured toseal the medical device package.

Another example embodiment includes a system for sealing and bursttesting a medical device package. The system includes a nozzle, wherethe nozzle is configured to be inserted into a medical device package.The system also includes an air pump, where the air pump is configuredto remove air from the medical device package through the nozzle andinsert air into the medical device package through the nozzle. Thesystem further includes a sealer, where the sealer is configured to sealthe medical device package, and a logic device, where the logic deviceis configured to control the operation to of the air pump and thesealer.

Another example embodiment includes a system for sealing and bursttesting a medical device package. The system includes a system housingand a sealer supported by the system housing, the sealer forming a sealon a medical device package by localized heating to a temperature thatmelts at least a portion of the medical device package. The systemincludes a nozzle supported by the system housing, where the nozzle isconfigured to be inserted into the medical device package, and an airpump supported by the system housing. The air pump is configured toremove air from the medical device package through the nozzle and insertair into the medical device package through the nozzle. The system alsoincludes a logic device supported by the system housing and coordinatingwith both the sealer and the air pump. During a sealing operation, thelogic device instructs the air pump to remove air from the medicaldevice package. During a burst testing operation, the logic deviceinstructs the air pump to reverse air flow and insert air into themedical device package. The logic device measures the maximum airpressure which is attained within the medical device package during theburst testing operation and compares the maximum air pressure to apredetermined threshold.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of some example embodiments of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates an example of a system for sealing a medical devicepackage;

FIG. 2 illustrates a block diagram of the components of the system forsealing a medical device package;

FIG. 3 illustrates an example of a medical device package in the processof being sealed;

FIG. 4 illustrates an example of a medical device package in the processof being tested; and

FIG. 5 is a flow chart illustrating a method of sealing and testing amedical device package.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS

Reference will now be made to the figures wherein like structures willbe provided with like reference designations. It is understood that thefigures are diagrammatic and schematic representations of someembodiments of the invention, and are not limiting of the presentinvention, nor are they necessarily drawn to scale.

FIG. 1 illustrates an example of a system 100 for sealing a medicaldevice package. In at least one implementation, the system 100 can beused to seal a medical device package such that the medical deviceremains sterile until needed in a medical procedure. In particular, thesterilized medical device can be vacuum sealed in a medical devicepackage such that the medical device cannot come in contact with outsidecontaminates, such as air, bacteria, biological fluids or othercontaminates.

FIG. 1 shows that the system 100 can include a housing 105. In at leastone implementation, the housing 105 is configured to surround the otherelements of the system 100. For example, the housing 105 can ensure thatelectrical elements are properly insulated from one another and fromoutside electrical signals or from other debris such as dust.Additionally or alternatively, the housing 105 can serve to ensure thatthe other elements of the system 100 are oriented correctly relative toone another. One of skill in the art will appreciate that the housing105 can cover all of the other components of the system 100 or only aportion thereof and that the housing 105 need not be exterior to theother components of the system 100.

FIG. 1 also shows that the system 100 can include a sealer 110. In atleast one implementation, the sealer 110 is configured to seal themedical device package. In particular, the sealer 110 can melt a portionof the medical device package to provide a seal that is air tight andwater resistant. As used in the specification and the claims the termair tight shall mean that the seal does not allow air to pass throughthe seal. I.e., the seal allows the medical device package to maintainvacuum pressure, or other non-ambient air pressure within the medicaldevice package.

FIG. 1 shows that the sealer 110 can include a jaw mechanism 115. In atleast one implementation, the jaw mechanism 115 can include an upper jawand a lower jaw. A solenoid, pneumatic piston or other device can engagethe jaw mechanism 115 to pull the upper jaw down onto the lower jaw, orvice versa, in order to apply the necessary pressure to the flexiblepackage or pouch. The pressure exerted by the jaw mechanism 115 can becontrolled by a control knob, controlled electronically or controlled insome other manner to ensure that the pressure is consistent.

In at least one implementation, the sealer 110 can also include aheating element. The heating element can flash heat to a predeterminedtemperature to melt at least a portion of the packaging material. Theheating element can maintain the temperature for a specific time tocreate a bond among the two sides of the medical device package. Piecesof Teflon, Sarcon, and glass cloth can be disposed on either side of thejaw mechanism 115 to prevent the medical device packaging materials fromsticking to the jaw mechanism 115.

FIG. 1 further shows that the system 100 can include a nozzle 120. In atleast one implementation, the nozzle 120 is configured to be insertedinto a medical device package. The nozzle 120 can then be used to removeair from the medical device package or insert air into the medicaldevice package, as described below. In particular, the medical devicepackage can be substantially sealed then the nozzle 120 can be insertedinto the unsealed portion of the medical device package. The air canthen be removed during a sealing operation or inserted during a bursttesting operation, as described below.

FIG. 1 also shows that the system 100 can include a data port 125. In atleast one implementation, the data port 125 can be used to transmit databetween the system 100 and an external system. For example, the dataport 125 can be used to transmit burst testing results. Additionally oralternatively, the data port 125 can be used to receive software updatesor to change settings of the system 100.

FIG. 1 further shows that the system 100 can include a display 130. Inat least one implementation, the display 130 can provide status updatesto a user. For example, the display 130 can display the results ofrecent burst testing operations. Additionally or alternatively, thedisplay 130 can be used to change settings of the system 100. Forexample, the display 130 can include a touch screen display that isallows a user to look up and modify settings of the system 100.

FIG. 2 illustrates a block diagram of the components of the system 100for sealing a medical device package. In at least one implementation,the components of the system 100 can be used to seal a medical devicepackage, as described above. One of skill in the art will appreciatethat the components can be combined, separated or connected inalternative schemes without restriction, unless otherwise stated in thespecification or the claims.

FIG. 2 shows that the system 100 can include a logic device 205. In atleast one implementation, a logic device 205 can include any devicecapable of performing logic functions. For example, the logic device 205can perform Boolean logic or can produce a pre-determined output basedon input. The logic device 205 can include ROM memory, programmablelogic device (PLD), programmable array logic (PAL), generic array logic(GAL), complex programmable logic device (CPLD), field programmable gatearrays (FPGA), logic gates, processors or any other device capable ofperforming logic functions.

In at least one implementation, the logic device 205 can control thefunctions of the other components of the system 100. In particular, thelogic device 205 can ensure that the components of the system 100perform their desired function at the appropriate time and in theappropriate manner. The timing of functions can be critical to ensurethat the medical device package is sealed properly to keep the medicaldevice stored in a sanitary condition.

FIG. 2 shows that the logic device 205 is connected to the sealer 110.In at least one implementation, the sealer 110 is configured to seal themedical device packaging, as described above. For example, the medicaldevice packaging can be partially or completely sealed prior toinsertion of the medical device. The sealer 110 can then be used tocomplete the seal of the medical device packaging after the medicaldevice has been inserted.

In at least one implementation, the logic device 205 can control theoperation of the sealer 110. In particular, after the air is removedfrom the medical device package, the logic device 205 can control thejaw mechanism 115 to hold the medical device package closed. The logicdevice 205 can then turn on the heating element 210 to complete theseal. After the seal has set, the logic device 205 can open the jawmechanism 115 to release the medical device package. The logic device205 can use a sensor to determine when to move from one step to the nextor can time each step to occur at the appropriate time.

FIG. 2 also shows that the system 100 can include a nozzle insertiondevice 215. In at least one implementation, the nozzle insertion device215 can move the nozzle 120 into and out of the medical device package.One of skill in the art will appreciate that the nozzle 120 insertion orremoval can be accomplished by moving the nozzle or the medical devicepackage or in any other manner. For example, the nozzle 120 can be movedwhile the medical device package is held stationary by the jaw mechanism115. Alternatively, the jaw mechanism 110 or an operator can move themedical device package onto the nozzle 120.

FIG. 2 shows that the logic device 205 can be connected to the nozzleinsertion device 215. In at least one implementation, the logic device205 can control the insertion or removal of the nozzle 120 into or outof the medical device package respectively. For example, when themedical device package is in place, the logic device 205 can move thenozzle 120 using the nozzle insertion device 215 such that a portion ofthe nozzle 120 is within the medical device package and capable ofallowing air to be removed from the medical device package, as describedbelow. Alternatively, when the air has been removed from the medicaldevice package, the logic device 205 can instruct the nozzle insertiondevice 215 to remove the nozzle 120 from the medical device package sothat the sealer 110 can seal the medical device package.

FIG. 2 further shows that the system 100 can include an air pump 220. Inat least one implementation, the air pump 220 can be connected to thenozzle 120 for removing air from the medical device packaging. Forexample, the air pump 220 can remove air from the medical device packagebefore the medical device package is sealed. Additionally oralternatively, the air pump 220 can insert air into the medical devicepackage in order to determine if the seal meets the required safetystandards.

In at least one implementation, the logic device 205 can be capable ofcontrolling the air pump 220. In particular, the logic device 205 canpump air from the medical device package during a sealing operation.Alternatively, the logic device 205 can reverse the air flow through thenozzle 120 such that the air pump 220 is inserting air into the medicaldevice package during a burst testing operation.

FIG. 2 shows that the air pump 220 can include an air pressure sensor225. In at least one implementation, the air pressure sensor 225 canmeasure the air pressure within the medical device package. For example,if the air pump 220 is removing air form the medical device packageduring a sealing operation the air pressure sensor 225 can determinewhen an acceptable amount of air has been removed. Additionally oralternatively, the air pressure sensor 225 can determine the maximum airpressure attained within the medical device package before the packagebursts during a testing operation.

In at least one implementation, the logic device 205 can compare themaximum air pressure attained within the medical device package todetermine if the seal conforms to the required standards. For example,the air pressure required to burst the package can be compared to theASTM F1140 requirements for Internal Pressurization Failure Resistanceof Unrestrained Packages and or the ISO 11607 standard for packaging forterminally sterilized medical devices which references are incorporatedherein by reference in their entirety. If the maximum air pressureindicates that the seal was inadequate, the logic device 205 can stopoperation of the system 100 and alert a user so that the user candetermine if the seals are being created adequately or if changes orrepairs need to be made.

FIG. 2 further shows that the system 100 can include a memory 230. In atleast one implementation, the memory 230 can include any device capableof storing data in computer readable form. The memory 230 can includevolatile memory and non-volatile memory. Volatile memory can includedynamic random access memory (DRAM), static random access memory (SRAM),thyristor random access memory (T-RAM), zero capacitor random accessmemory (Z-RAM), twin transistor random access memory (TTRAM), delay linememory, selectron tube and williams tube. Non-volatile memory caninclude read-only memory (ROM), programmable read only memory (PROM),erasable programmable read only memory (EPROM), electrically erasableprogrammable read only memory (EEPROM), flash memory, ferroelectricrandom access memory (FeRAM), magnetoresistive random access memory(MRAM), phase change random access memory (PRAM, aka PCM, PRAM, PCRAM,ovonic unified Memory, chalcogenide random access memory and C-RAM),conductive-bridging random access memory (CBRAM aka. programmablemetallization cell or PMC), silicon-oxide-nitride-oxide-silicon (SONOS),resistive random-access memory (RRAM), racetrack memory, nano randomaccess memory (NRAM), millipede, drum memory, magnetic core memory,plated wire memory, bubble memory and twistor memory.

In at least one implementation, the memory 230 can be used to storeresults of the comparisons done by the logic device 205. I.e., thememory 230 can store the results of recent tests to be accessed asdesired by a user. Additionally or alternatively, the memory 230 canstore the required standards, against which the measured air pressurewill be compared by the logic device 205.

FIG. 3 illustrates an example of a medical device package 305 in theprocess of being sealed. In at least one implementation, the medicaldevice package 305 is configured to allow a medical device 310 to bestored in a sterile environment. In particular, the sterilized medicaldevice 310 can be vacuum sealed in the medical device package 305 suchthat the medical device 310 cannot come in contact with outsidecontaminates, such as air, bacteria, biological fluids or othercontaminates.

FIG. 3 shows that the medical device package 305 can include presealedportions 315. In at least one implementation, the presealed portions 315can be sealed prior to the insertion of the medical device 310 into themedical device package 305. Additionally or alternatively, the presealedportions 315 can be sealed after the medical device 310 has beeninserted into the medical device package 305.

FIG. 3 also shows that the medical device package 305 can be placed withthe nozzle 120 within the medical device package 305. In particular, thenozzle 120 can be placed within the medical device package 305 to removethe air from the medical device package 305 during a sealing operation.The nozzle 120 can be flat or substantially flat in order to allow themedical device package 305 to be sealed, as described above.

FIG. 3 further shows that the jaw mechanism 115 can be closed around aportion of the medical device package 305. In at least oneimplementation, the jaw mechanism 115 can hold the unsealed portion ofthe medical device package 305 during air removal and sealing. This canallow the air within the medical device package 305 to be removedthrough the nozzle 120. I.e., the nozzle 120 remains the only open areathrough which air can enter or exit the medical device package 305. Theunsealed portion of the medical device package 305 can then be sealedusing a heating mechanism, as described above.

FIG. 4 illustrates an example of a medical device package 305 in theprocess of being tested. In at least one implementation, the testdetermines the pressure at which any portion of the seals in the medicaldevice package 305 burst or fail. I.e., the pressure at which anyportion of the seals burst is determined and compared against applicablestandards to ensure that the seals are sufficient to protect the medicaldevice 310 against contaminates. One of skill in the art will appreciatethat the burst testing operation can be completed immediately after thesealing operation. That is, the same system can be used to seal themedical device package 305 and test the seals.

FIG. 4 shows that the medical device package 305 can remain with thenozzle 120 within the medical device package 305. In at least oneimplementation, the nozzle 120 can remain within the medical devicepackage 305 to insert air into the medical device package 305 during aburst testing operation. I.e., the nozzle 120 can be used to insert airinto the medical device package 305, until the medical device package305 bursts and the maximum air pressure attained can be measured andcompared to the applicable standards for a burst testing operation.

FIG. 4 further shows that the jaw mechanism 115 can be opened during thetesting operation. In at least one implementation, the jaw mechanism 115can be opened to ensure that any resistance of the seals to bursting isnot enhanced by the closed jaw mechanism 115. I.e., the burst testingoperation can be performed with the jaw mechanism 115 open to ensurethat the seals alone are tested.

In at least one implementation, the air pressure can be monitored duringinsertion of the air into the medical device package 305. The maximumpressure attained can then be compared to a minimum acceptablethreshold. If the maximum pressure meets or exceeds the minimumacceptable threshold, the seal is deemed to be acceptable. If themaximum pressure is lower than the minimum acceptable threshold, theseal is deemed unacceptable and the operator is alerted to the failure.

FIG. 5 is a flow chart illustrating a method 500 of sealing and testinga medical device package. In at least one implementation, the medicaldevice package can be tested to ensure that it conforms to governmentalregulations or other packaging requirements. The testing can be done atregular intervals or when there is need for immediate testing. One ofskill in the art will appreciate that the method 500 can be used withthe system 100 of FIG. 1; however, the method 500 can be used with asystem other than the system 100 of FIG. 1.

FIG. 5 shows that the method 500 can include sealing a medical devicepackage 505. In at least one implementation, the medical device packagecan have the air removed before the sealing operation. Removing the aircan help thwart the possible decay of imbedded drugs on the medicaldevice by removing the ambient air that would contact the medical deviceplaced within the medical device package. In particular, the lack of aircan prevent unwanted bursting or popping of the medical device package.Additionally or alternatively, the lack of air can prevent pathogensfrom growing within the medical device package.

FIG. 5 also shows that the method 500 can include inflating the medicaldevice package 510. In at least one implementation, the medical devicepackage can be inflated until it bursts. The medical device package canbe inflated using a nozzle left in place when the medical device packageis sealed. Additionally or alternatively, a nozzle can be inserted intothe medical device package for the purpose of inflating the package.

FIG. 5 further shows that the method 500 can include determining whetherthe burst pressure exceeds the maximum allowable threshold 515. In atleast one implementation, the air pressure within the medical devicepackage can be monitored while air is being added to the medical devicepackage with the burst pressure indicating the maximum air pressureattained within the medical device package.

FIG. 5 also shows that the method 500 can include deeming the testsuccessful if the burst pressure is equal to or exceeds the maximumallowable threshold 520. In contrast, the method 500 can include deemingthe test a failure if the burst pressure does not exceed the maximumallowable threshold 525. In at least one implementation, if the test isa failure, a user can be notified or other corrective action can betaken to ensure that the medical device packaging is being properlysealed.

One of skill in the art will appreciate that, for this and otherprocesses and methods disclosed herein, the functions performed in theprocesses and methods may be implemented in differing order.Furthermore, the outlined steps and operations are only provided asexamples, and some of the steps and operations may be optional, combinedinto fewer steps and operations, or expanded into additional steps andoperations without detracting from the essence of the disclosedembodiments.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A system for sealing and burst testing a medical device package, thesystem comprising: a nozzle, wherein the nozzle is configured to beinserted into a medical device package; an air pump, wherein the airpump is configured to: remove air from the medical device packagethrough the nozzle; and insert air into the medical device packagethrough the nozzle for burst testing; and a sealer, wherein the sealeris configured to seal the medical device package.
 2. The system of claim1 further comprising a sensor, wherein the sensor is configured tomeasure the air pressure within the medical device package.
 3. Thesystem of claim 2, wherein the sensor instructs the sealer to seal themedical device package when the air pressure goes below a thresholdpressure.
 4. The system of claim 2, wherein the sensor is configured tomeasure the air pressure at which the medical device package bursts. 5.The system of claim 1, wherein the nozzle is configured to be retractedfrom the medical device package prior to the sealer sealing at least aportion of the medical device package.
 6. The system of claim 1, whereinthe air pump is further configured to reverse the direction of air flow.7. The system of claim 1, wherein the air pump is configured to insertair into the medical device package until the medical device packagebursts.
 8. The system of claim 1, wherein the sealer is configured tomelt at least a portion of the medical device package.
 9. The system ofclaim 1 further comprising an insertion device, wherein the insertiondevice is configured to insert the nozzle into the unsealed medicaldevice package.
 10. The system of claim 9, wherein the insertion deviceis configured to insert the nozzle into the sealed medical devicepackage.
 11. A system for sealing and burst testing a medical devicepackage, the system comprising: a nozzle, wherein the nozzle isconfigured to be inserted into a medical device package, an air pump,wherein the air pump is configured to: remove air from the medicaldevice package through the nozzle; and insert air into the medicaldevice package through the nozzle; a sealer, wherein the sealer isconfigured to seal the medical device package; and a logic device,wherein the logic device is configured to control the operation to ofthe air pump and the sealer.
 12. The system of claim 11, wherein thelogic device includes a processor.
 13. The system of claim 11, whereinthe logic device instructs the air pump to remove air from the medicaldevice package during a sealing operation.
 14. The system of claim 13,wherein the air pump continues to remove air from the medical devicepackage until the air pressure drops below a predetermined threshold.15. The system of claim 11, wherein the logic device is configured tonotify an operator if the air pressure fails to drop below thepredetermined threshold after a certain period of time.
 16. A system forsealing and burst testing a medical device package, the systemcomprising: a system housing; a sealer supported by the system housing,the sealer forming a seal on a medical device package by localizedheating to a temperature that melts at least a portion of the medicaldevice package; a nozzle supported by the system housing, wherein thenozzle is configured to be inserted into the medical device package, anair pump supported by the system housing, wherein the air pump isconfigured to: remove air from the medical device package through thenozzle; and insert air into the medical device package through thenozzle; and a logic device supported by the system housing andcoordinating with both the sealer and the air pump; wherein, during asealing operation, the logic device instructs the air pump to remove airfrom the medical device package; wherein, during a burst testingoperation, the logic device instructs the air pump to reverse air flowand insert air into the medical device package; wherein the logic devicemeasures the maximum air pressure which is attained within the medicaldevice package during the burst testing operation; and wherein the logicdevice compares the maximum air pressure to a predetermined threshold.17. The system of claim 16, wherein the logic device stops operation andnotifies an operator if the maximum air pressure is below thepredetermined threshold.
 18. The system of claim 16, wherein the logicdevice is configured to perform a burst testing operation after thesystem has performed a predetermined number of sealing operationswithout a burst testing operation.
 19. The system of claim 16 furthercomprising a memory, wherein the memory is configured to record theresults of prior burst testing operations.
 20. The system of claim 16further comprising an output port, wherein the output port is configuredto transmit the result of the comparison by the logic device of themaximum air pressure to the predetermined threshold.